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Valdoxan More Effective On Patients With Major Depressive Disorder Than Common Antidepressants

Published
Tuesday 6 September 2011 Published Tue 6 Sep 2011

By Grace Rattue

The European College of Neuropsychopharmacology Congress (ECNP) highlighted new data regarding the high efficiency of Valdoxan® (agomelatine) in comparison with other commonly prescribed antidepressants showing that the drug is stronger and therefore significantly more beneficial for depressed patients with severe anxiety symptoms. Valdoxan®, available in over 40 countries worldwide was authorized in the EU in February 2009 for treatment of adult patients with MDD.

The new data is based on the analysis on the total of nearly 2,000 patients with major depressive disorder (MDD) from six large multi-center studies, each lasting between 6 and 8 weeks. Participants' depression levels were measured by a score of at least 5 points on the anxiety subscale of the Hamilton Depression Rating Scale (HAM-D), which identified 900 of the total patients as being severely anxious.

Research was split into different study groups, including three of the six studies comparing Valdoxan to the selective serotonin reuptake inhibitors (SSRIs) sertraline and fluoxetine, and the serotonin noradrenalin reuptake inhibitor (SNRI) venlafaxine, with the remaining three studies comparing Valdoxan to placebo.

Prof. Dan Stein, Professor and Chair of the Dept. of Psychiatry and Mental Health at the University of Cape Town in South Africa explained:

"These new data are important, because anxiety within depression is common and associated with worse prognosis, increased disability and higher use of medication. This new evidence establishes the novel antidepressant agomelatine as a promising treatment option for the management of anxiety in patients suffering from depression."

Researchers found that Valdoxan reduced anxiety scores in the HAM-D anxiety sub-score as early as the second week (p
Compared to the other drugs in the study, Valdoxan proved to be more effective in reducing anxiety symptoms and produced a substantial difference on the Hamilton Anxiety Rating Scale (HAM-A) of 1.39 points (p=0.006). Compared to the most commonly prescribed antidepressants, Valdoxan's beneficial effects were even greater in highly anxious depressed patients, recording a difference of 1.72 on the HAM-A Scale (p=0.032).

Prof. Sidney Kennedy, Professor of Psychiatry at the University of Toronto in Canada pointed out:

"In addition to the strong existing evidence of its antidepressant efficacy, these new data reinforce agomelatine's powerful efficacy for the management of anxiety versus other commonly used antidepressants. In addition, this efficacy is seen in clinical settings with patients reporting 'feeling better' and being 'less anxious' as early as the second week of treatment."

As the first antidepressant simultaneously acting as MT1 and MT2 melatonergic receptors agonist and a 5-HT2C antagonist, Valdoxan re-synchronizes circadian rhythms that are heavily disrupted in depressed patients, offering a totally innovative alternative to treating depression.

Clinicians can achieve greater efficacy with Valdoxan in reducing depression and anxiety symptoms in patients suffering from depression, including those with marked anxiety symptoms, because Valdoxan is the first antidepressant with a non-monoaminergic component.

Valdoxan® international development program

Several clinical trials within the international development program have displayed Valdoxan's efficacy in major depressive disorder (MDD). This study, consisting of nearly 6,000 depressed patients, indicated Valdoxan's unique clinical signature and its distinctive profile compared with placebo, SSRIs and SNRI treatments.

Results of the studies demonstrated that Valdoxan:

is more efficient in the treatment of all stages of depression compared with conventional antidepressants, showing greater patient improvement following the first week of treatment, irrespective of the intensity of depressive symptoms even in the more severely depressed patients

produces a significant reduction of relapse incidence in depressive patients over the long-term

does not affect sexual functioning and weight, offering a favorable tolerability profile, leading to better adherence and remission in depressed patients

is easily administered: one 25 mg tablet taken at bedtime, without discontinuation symptoms at the end of treatment

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Comments(3)

Trials of psychoactive drugs compared to placebo are almost certain to break blind and thus produce an enhanced placebo effect for the active drug and an enhanced negative, "nocebo" effect, for the placebo. This is because the participants, depressed people who want to get better, experience the recognizable side effects of the active drug, realize that that's what they're getting, and have every reason to believe that they will be getting better. That rosy expectation is the reverse of what the mood disorder of depression is and so nobody should be surprised that they'll test better on a ham-d or ham-a. Participants with the placebo are in the opposite situation: they see they are not experiencing the drug side effects, conclude accurately that they are in the placebo group and that their disorder is not being treated and that they have no reason to suppose they will get better. This is, of course, exactly the kind of expectation set that will show up on the scale as increased depression or anxiety symptoms.

What is true of the participants is even more true of the researchers as they question participants during the course of the trial and who are hoping for validation of their belief that they are on to a promising drug. They see the presence and absence of side effects, too, and correctly identify which participants are in the experimental and which in the control groups.

In the largest study of its kind, 80 percent of the participants and 87 percent of the researchers correctly identified who was in each group.

This isn't rocket science: failure to recognize this problem shows plain old bad faith and questionable results, at best.

I have been on Valdoxan for 8 months after a serious breakdown in which I was hospitalized for 2 weeks. I was diagnosed with severe depression and acute anxiety brought on by a big change in my life due to personal reasons. Prior to my hospital admission, I was on Fluanxol, Cylift and various others that gave me bad side effects - the most severe being chronic headaches.
I am delighted to say that Valdoxan is THE ONLY medication, of ALL the meds (7 different types) that I was prescribed, that has truly changed my life. I sleep really well, anxiety has reduced phenomenally, no more bad bouts of crying and feeling really helpless, my libido has not been affected at all and I have a very positive outlook on life. I thank God for Valdoxan and the people that were responsible for developing this drug. Thank you, thank you, thank you!

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